Topic:

Regulatory

Latest Headlines

Latest Headlines

Insulet says troubled wearable insulin pump plant back on track, just as FDA issues recall notice

Insulet said its long-troubled Billerica, MA manufacturing plant is back on track on an earnings call earlier this month--just before the FDA offered details on the OmniPod recalls that were caused by inadequate standards compliance. In July, the company issued a voluntary recall of more than 400,000 OmniPod Insulin Management Systems, which are wearable insulin pumps.  

Judge halts lawsuit blaming Purdue, Endo and others for epidemic of drug abuse

It was attention-grabbing when California sued a handful of drugmakers, accusing them of lying about the safety of their high-powered painkillers and blaming them for an epidemic of prescription drug overdoses and a resurgence in heroin use. But from a legal standpoint, a California judge has ruled, there is not much there to stand on.

China slaps Pfizer with $500,000 in Viagra penalties for pharmacy tie-up

Pfizer has no problem keeping sales for Viagra flying high in China, where brand awareness campaigns and changing attitudes toward sex have given it a sizable hold on the ED market. But the company is facing some headwind in the country, as Chinese marketing authorities slapped Pfizer with a fine for paying local drugstores to promote its blockbuster ED med.

The FDA offers a controversial solution to the biosimilars name game

The industry has been wrestling for years now over naming the first wave of biosimilars building on the coast of the American drug industry. The FDA's suggested solution: Take the generic name and add four random letters to make it a unique identifier.

UPDATED: Amgen gets a big win with FDA OK for PCSK9 cholesterol drug Repatha

Amgen scored the big win for its PCSK9 drug Repatha (evolocumab). The FDA announced Thursday afternoon that it has given Amgen a green light on marketing the PCSK9 cholesterol drug, opening the door to what will likely prove a blockbuster market.

FDA scolds Cepheid for manufacturing issues in Sweden

The FDA slapped Cepheid with a warning letter for violations at its European R&D and manufacturing site in Sweden, chastising the company for the way it went about producing its Xpert Norovirus diagnostic.  

The FDA has spoken on biosimilar names. But will its hybrid proposal work?

After much industry lobbying and public debate, the FDA has proposed a system for naming biosimilar drugs. It's a sort of hybrid of the generic name on one hand and the unique brand name on the other. And it would allow the FDA to make some biosims easy to substitute for the brand-name original--and others not so easy.

Sun faces class action suit over closure of Caraco plants 6 years ago

It has been more than 6 years since Caraco Pharmaceutical Laboratories was forced to suddenly shut two Detroit-area manufacturing plants after the FDA sent in marshals to seize drugs, claiming the plants had contamination issues. One of the plants was even closed last year by Caraco owner Sun Pharmaceutical. But legal problems continue to reverberate for Sun for having laid off hundreds of workers without notice.

Woodcock says FDA will keep new plant quality grades a secret

The FDA publishes warning letters and inspection reports on its websites. It issues public recalls and drug label warnings. However, it is not feeling in such a sharing mood when it comes to its proposed letter grades for manufacturing plants on the quality of their manufacturing.

India's Gujarat state moves closer to country's first medical device testing lab

A lab dedicated to biocompatibility and medical device testing to be based in India's western Gujarat state, a manufacturing hub, would mark a first and has received backing from the federal government with hopes of getting state officials to offer funds as well.